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Darunavir Tablets and Rosuvastatin Tablets

Determining the interaction of Darunavir Tablets and Rosuvastatin Tablets and the possibility of their joint administration.

Check result:
Darunavir Tablets <> Rosuvastatin Tablets
Relevance: 17.05.2023 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Darunavir may significantly increase the blood levels of rosuvastatin. This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness while taking rosuvastatin or similar medications, especially if these symptoms are accompanied by fever or dark colored urine. You should also seek immediate medical attention if you develop fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

ADJUST DOSE: Coadministration with protease inhibitors may significantly increase the plasma concentrations of rosuvastatin. The mechanism may involve inhibition of OATP1B1-mediated hepatic uptake and/or BCRP-mediated intestinal and hepatobiliary efflux. In 15 healthy volunteers, administration of rosuvastatin 20 mg once a day with lopinavir-ritonavir 400 mg-100 mg twice a day for 7 days was associated with an approximately 5-fold increase in rosuvastatin steady-state peak plasma concentration (Cmax) and a 2-fold increase in systemic exposure (AUC) compared to administration of rosuvastatin alone. One subject had asymptomatic creatine phosphokinase elevation 17 times the upper limit of normal (ULN) and another had liver function test elevation between 1.1 and 2.5 times ULN. In a study with 11 subjects, administration of rosuvastatin 5 mg once daily in combination with once daily morning doses of ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg) plus twice daily doses of dasabuvir resulted in increases of rosuvastatin Cmax and AUC by approximately 7.1- and 2.6-fold, respectively. Likewise, atazanavir/ritonavir 300 mg/100 mg given once daily for 8 days increased the Cmax and AUC of a single 10 mg dose of rosuvastatin by 7.0- and 3.1-fold, respectively. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death.

MANAGEMENT: The benefits of using rosuvastatin with protease inhibitors should be carefully weighed against the potentially increased risk of myopathy including rhabdomyolysis. If coadministration is required, the lowest effective dosage of rosuvastatin should be used and close monitoring for musculoskeletal toxicity is recommended. The dosage of rosuvastatin should be limited to 10 mg once a day when used with lopinavir-ritonavir, atazanavir-ritonavir, atazanavir-cobicistat, or ombitasvir/paritaprevir/ritonavir plus dasabuvir. Alternatively, a different HMG-CoA reductase inhibitor such as fluvastatin may be considered. All patients receiving statin therapy should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.

References
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  • "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb, Princeton, NJ.
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  • "Product Information. Invirase (saquinavir)." Roche Laboratories, Nutley, NJ.
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  • "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline, Research Triangle Park, NC.
  • "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc, Mississauga, ON.
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Darunavir Tablets

Generic Name: darunavir

Brand name: Prezista

Synonyms: Darunavir

Rosuvastatin Tablets

Generic Name: rosuvastatin

Brand name: Crestor, Ezallor Sprinkle

Synonyms: Rosuvastatin

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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